Oral care compositions and methods of use

ABSTRACT

This invention relates to oral care compositions comprising arginine or lysine, zinc citrate and zinc oxide, fluoride source, and a silica abrasive which exhibits an acid pH when measured as an aqueous slurry as well as to methods of using and of making these compositions.

FIELD

This invention relates to oral care compositions comprising arginine orlysine or salt thereof, zinc oxide and zinc citrate, a fluoride source,and a silica which exhibits an acid pH when measured as an aqueousslurry, as well as to methods of using and of making these compositions.

BACKGROUND

Commercially available arginine-based contains arginine bicarbonate andprecipitated calcium carbonate. The carbonate ion is believed to havecariostatic properties, and the calcium is believed to form a complexwith arginine to provide a protective effect.

Viscosity stability is an important aesthetic aspect for many oral carecompositions. However, developing and improving viscosity can bechallenging.

Accordingly, there is a need for improved formulations oral compositionscomprising basic amino acids with acceptable viscosity.

BRIEF SUMMARY

It has been surprisingly found that a composition containing a silicaabrasive which provides an acid pH when slurried with water unexpectedlyprovides viscosity stability over time in oral care compositionscomprising an amino acid, arginine or lysine, and a zinc oxide and/orzinc citrate, selected at certain concentrations and amounts.

The current formulations offer the advantage of robust microbialprotection and viscosity stability of the oral care composition and byallowing for formulations which use less zinc—which may have undesirableaesthetic qualities (e.g., poor taste). Without being bound by anytheory, it is believed that the presence of silica abrasive whichprovides an acid pH when slurried with water stabilizes otherformulation ingredients against degradation in the presence of the aminoacid in a manner that silicas of neutral or basic pH do not provide.

In one aspect the invention is an oral care composition (Composition1.0) comprising:

-   -   a. A basic amino acid in free or salt from, wherein the amino        acid is selected from arginine, lysine, and combinations        thereof; (e.g., free form arginine);    -   b. zinc oxide and zinc citrate;    -   c. a fluoride source (e.g., sodium fluoride); and    -   d. a silica abrasive which exhibits an acid pH when measured as        an aqueous slurry (e.g., prophy silica).

For example, the invention contemplates any of the followingcompositions (unless otherwise indicated, values are given as percentageof the overall weight of the composition):

-   -   1.01 Composition 1.0 wherein the silica abrasive which exhibits        an acid pH when measured as an aqueous slurry is prophy    -   1.02 Any of the preceding compositions wherein the silica        abrasive which exhibits an acid pH when measured as an aqueous        slurry is Sylodent 783.    -   1.03 Any of the preceding compositions wherein the silica        abrasive exhibits a pH of 3.5-4.5 in an aqueous slurry of the        abrasive.

1.04 Any of the preceding compositions wherein the silica abrasive whichexhibits an acid pH when measured as an aqueous slurry is present in anamount from 2 to 35 weight percent.

1.05 Any of the preceding compositions wherein the silica abrasive whichexhibits an acid pH when measured as an aqueous slurry is present in anamount from 3 to 15 weight percent.

1.06 Any of the preceding compositions wherein the silica abrasive whichexhibits an acid pH when measured as an aqueous slurry is present in anamount selected from 2 wt. %, 3 wt. %; 4 wt. %, 5 wt. %, 6 wt. %, 7 wt.%, 8 wt. %, 9 wt %, 10 wt. %, 11 wt. %, 12 wt. %, 13 wt. %, 14 wt. %, 15wt. %, 16 wt. %, 17 wt. %, 18 wt. %, 19 wt. %, 20 wt. %.

-   -   1.07 Any of the preceding compositions wherein the basic amino        acid has the configuration (e.g., L-arginine).    -   1.08 Any of the preceding compositions wherein the basic amino        acid is arginine or lysine is in free form.    -   1.09 Any of the preceding compositions wherein the basic amino        acid is provided in the form of a di- or tri-peptide comprising        arginine or lysine, or salts thereof.    -   1.10 Any of the preceding compositions wherein the basic amino        acid is arginine or lysine, and wherein the arginine or lysine        is present in an amount corresponding to 1% to 15%, e.g., 3 wt.        % to 10 wt. % of the total composition weight, about e.g., 1.5%,        4%, 5%, or 8%, wherein the weight of the basic amino acid is        calculated as free form.    -   1.11 Any of the preceding compositions wherein the amino acid is        arginine from 0.1 wt. %-6.0 wt. % (e.g., about 1.5 wt %).    -   1.12 Any of the preceding compositions wherein the amino acid is        arginine from about 1.5 wt. %.    -   1.13 Any of the preceding compositions wherein the amino acid is        arginine from 4.5 wt. %-8.5 wt. % (e.g., 5.0%).    -   1.14 Any of the preceding compositions wherein the amino acid is        arginine from about 5.0 wt. %.    -   1.15 Any of the preceding compositions wherein the amino acid is        arginine from 3.5 wt. %-9 wt. %.    -   1.16 Any of the preceding compositions wherein the amino acid is        arginine from about 8.0 wt. %.    -   1.17 Any of the preceding compositions wherein the amino acid is        L-arginine.    -   1.18 Any of the preceding compositions wherein the amino acid is        a free form arginine.    -   1.19 Any of the preceding compositions wherein the basic amino        acid is lysine (e.g., 2% wt., 3% wt., 4% wt., 5% wt., 6% wt.),        (e.g., 4% wt.).    -   1.20 Any of the preceding compositions wherein the amino acid is        lysine from 1.0 wt. %-6.0 wt %.    -   1.21 Any of the preceding compositions wherein the amino acid is        lysine from about 1.5 wt. %.    -   1.22 Any of the preceding compositions wherein the amino acid is        lysine from about 4.0 wt. %.    -   1.23 Any of the preceding compositions wherein the amino acid is        L-lysine.    -   1.24 Any of the preceding compositions wherein the amino acid is        free form lysine.    -   1.25 Any of the preceding compositions wherein the amino acid is        arginine or lysine in partially or wholly in salt form.    -   1.26 Composition 1.25 wherein the amino acid is arginine        phosphate.    -   1.27 Composition 1.25 wherein the amino acid is arginine        hydrochloride.    -   1.28 Composition 1.25 wherein the amino acid is arginine        bicarbonate.    -   1.29 Composition 1.25 wherein the amino acid is lysine        phosphate.    -   1.30 Composition 1.25 wherein the amino acid is lysine        hydrochloride.    -   1.31 Composition 1.25 wherein the amino acid is lysine        bicarbonate.    -   1.32. Any of the preceding compositions wherein the amino acid        is arginine or lysine ionized by neutralization with an acid or        a salt of an acid.    -   1.33 Any of preceding compositions wherein the composition is        ethanol-free.    -   1.34 Any of the preceding compositions further comprising a        fluoride source selected from: stannous fluoride, sodium        fluoride, potassium fluoride, sodium monofluorophosphate, sodium        fluorosilicate, ammonium fluorosilicate, amine fluoride (e.g.,        N-octadecyltrimethylendiamine-N,N,N′-tris(2-ethanol)-dihydrofluoride),        ammonium fluoride, titanium fluoride, hexafluorosulfate, and        combinations thereof.    -   1.35 The composition of 1.34, wherein the fluoride source is        stannous fluoride.    -   1.36 Any of the preceding compositions wherein the fluoride        source is a fluorophosphate.    -   1.37 Any of the preceding compositions wherein the fluoride        source is sodium monofluorophosphate.    -   1.38 The composition of 1.34, wherein the fluoride source is        sodium fluoride.    -   1.39 Any of the preceding compositions wherein the fluoride        source is a fluoride salt present in an amount of 0.1 wt. % to 2        wt. % (0.1 wt %-0.6 wt. %) of the total composition weight        (e.g., sodium fluoride (e.g., about 0.32 wt. %) or sodium        monofluorophosphate).    -   1.40 Any of the preceding compositions wherein the fluoride        source is sodium fluoride in an amount about 0.32 wt. % based on        the weight of the composition.    -   1.41 Any of the preceding compositions wherein the fluoride        source is a soluble fluoride salt which provides fluoride ion in        an amount of from 50 to 25,000 ppm (e.g., 750-2000 ppm, e.g.,        1000-1500 ppm, e.g., about 1000 ppm, e.g., about 1450 ppm)    -   1.42 Any of the preceding compositions wherein the fluoride        source is sodium fluoride which provides fluoride in an amount        from 750-2000 ppm (e.g., about 1450 ppm).    -   1.43 Any of the preceding compositions wherein the fluoride        source is selected from sodium fluoride and sodium        monofluorophosphate and which provides fluoride in an amount        from 1000 ppm-1500 ppm.    -   1.44 Any of the preceding compositions wherein the fluoride        source is sodium fluoride or sodium monofluorophosphate and        which provides fluoride in an amount of about 1450 ppm.    -   1.45 Any of the preceding compositions wherein the pH is between        6.0 and 10.5, e.g., 7.0 to 9.0, e.g., about 8.0.    -   1.46 Any of the preceding compositions further comprising        calcium carbonate.    -   1.47 The composition of 1.46, wherein the calcium carbonate is a        precipitated calcium carbonate high absorption (e.g., 20% to 30%        by weight of the composition) (e.g., 25% precipitated calcium        carbonate high absorption).    -   1.48 The composition of 1.47, further comprising a precipitated        calcium carbonate-light (e.g., about 10% precipitated calcium        carbonate-light) (e.g., about 10% natural calcium carbonate).    -   1.49 Any of the preceding compositions further comprising an        effective amount of one or more alkali phosphate salts, e.g.,        sodium, potassium or calcium salts, e.g., selected from alkali        dibasic phosphate and alkali pyrophosphate salts, e.g., alkali        phosphate salts selected from sodium phosphate dibasic,        potassium phosphate dibasic, dicalcium phosphate dihydrate,        calcium pyrophosphate, tetrasodium pyrophosphate, tetrapotassium        pyrophosphate, sodium tripolyphosphate, disodium        hydrogenorthophoshpate, monosodium phosphate, pentapotassium        triphosphate and mixtures of any of two or more of these, in an        amount of 0.1-20%, e.g., 0.1-8%, e.g., 0.2 to 5%, e.g., 0.3 to        2%, e.g., 0.3 to 1%, e.g about 0.5%, about 1%, about 2%, about        5%, about 6%, by weight of the composition.    -   1.50 Any of the preceding compositions comprising tetrapotassium        pyrophosphate, disodium hydrogenorthophosphate, monosodium        phosphate, and pentapotassium triphosphate.    -   1.51 Any of the preceding compositions, wherein the composition        further comprises stannous pyrophosphate, wherein the stannous        pyrophosphate is from 0.1%-3% by wt. of the composition. (e.g.,        about 1% by wt. of the composition).    -   1.52 Any of the preceding compositions comprising a        polyphosphate.    -   1.53 The composition of 1.49, wherein the polyphosphate is        tetrasodium pyrophosphate.    -   1.54 The composition of 1.53, Therein the tetrasodium        pyrophosphate is from 0.1-1.0 wt % (e.g., about 0.5 wt %).    -   1.55 Any of the preceding compositions further comprising a        second abrasive or particulate (e.g., silica).    -   1.56 Any of the preceding compositions wherein the second        abrasive silica is synthetic amorphous silica. (e.g., 1%-28% by        wt.) (e.g., 8%-25% by wt.)    -   1.57 Any of the preceding composition wherein the silica        abrasives are silica gels or precipitated amorphous silicas,        e.g. silicas having an average particle size ranging from 2.5        microns to 12 microns.    -   1.58 Any of the preceding compositions further comprising a        small particle silica having a median particle size (d50) of 1-5        microns (e.g., 3-4 microns) (e.g., about 5 wt. % Sorbosi AC43        from PQ Chemicals, Warrington, United Kingdom).    -   1.59 Any of the preceding compositions wherein 20-30 wt % of the        total silica in the composition is small particle silica (e.g.,        having a median particle size (d50) of 3-4 microns) and wherein        the small particle silica is about 5 wt. % of the oral care        composition.    -   1.60 Any of the preceding compositions comprising silica wherein        the silica is used as a thickening agent, e.g., particle silica.    -   1.61 Any of the preceding compositions further comprising a        nonionic surfactant, wherein the nonionic surfactant is in an        amount of from 0.5-5%, e.g, 1-2%, selected from poloxamers        (e.g., poloxamer 407), polysorbates (e.g., polysorbate 20),        polyoxyl hydrogenated castor oil (e.g., polyoxyl 40 hydrogenated        castor oil), and mixtures thereof.    -   1.62 Any of the preceding compositions, wherein the poloxamer        nonionic surfactant has an average polyoxypropylene molecular        mass (Mw) of from 3000 to 5000 g/mol and a polyoxyethylene        content of from 60 to 80 mol %, e.g., the poloxamer nonionic        surfactant comprises poloxamer 407.    -   1.63 Any of the preceding compositions further comprising        glycerin, wherein the glycerin is in a total amount of 25-40%        (e.g., about 35%).    -   1.64 The composition of 1.63, wherein the glycerin is in an        amount of about 35% by wt. of the composition.    -   1.65 The composition of 1.63, wherein the glycerin is in an        amount of about 26% by wt. of the composition.    -   1.66 Any of the preceding compositions further comprising        sorbitol, wherein the sorbitol is in a total amount of 10-40%        (e.g., about 23%).    -   1.67 The composition of 1.66, wherein the sorbitol is in an        amount of about 13% by wt. of the composition.    -   1.68 The composition of any of 1.63-1.67, wherein the glycerin        is an amount of about 26% by wt., and the sorbitol is in an        amount of about 13% by wt.    -   1.69 Any of the preceding compositions, wherein the ratio of the        amount of zinc oxide (e.g., wt. %) to zinc citrate (e.g., wt %)        is from 1.5:1 to 4.5:1 (e.g., 2:1, 2.5:1, 3:1, 3.5:1, or 4:1).    -   1.70 Any of the preceding compositions, wherein the zinc citrate        is in an amount of from 0.25 to 1.0 wt % (e.g., 0.5 wt. %) and        zinc oxide may be present in an amount of from 0.75 to 1.25 wt %        (e.g., 1.0 wt. %) based on the weight of the oral care        composition.    -   1.71 Any of the preceding compositions wherein the zinc citrate        is about 0.5 wt %.    -   1.72 Any of the preceding compositions wherein the zinc oxide is        about 1.0 wt %.    -   1.73 Any of the preceding compositions where the zinc citrate is        about 0.5 wt % and the zinc oxide is about 1.0 wt %.    -   1.74 Any of the preceding compositions further comprising an        additional ingredient selected from: benzyl alcohol,        Methylisothizolinone (“MIT”), Sodium bicarbonate, sodium methyl        cocoyl taurate (tauranol), lauryl alcohol, and polyphosphate.    -   1.75 Any of the preceding compositions wherein the benzyl        alcohol is present from 0.1-0.6 wt %, (e.g., 0.1-0.4 wt %) e.g.        about 0.1 wt. %, about 0.2 wt. %, or about 0.3 wt. %.    -   1.76 Any of the preceding compositions wherein the benzyl        alcohol is about 0.1 wt %.    -   1.77 Any of the preceding compositions wherein the benzyl        alcohol is considered a preservative.    -   1.78 Any of the preceding compositions comprising polymer films.    -   1.79 Any of the preceding compositions comprising flavoring,        fragrance and/or coloring.    -   1.80 The composition of 1.65, wherein the flavoring agent is        sodium saccharin, sucralose, or a mixture thereof.    -   1.81 Any of the preceding compositions, wherein the composition        comprises a thickening agents selected from the group consisting        of carboxyvinyl polymers, xanthan gum, carrageenan, hydroxyethyl        cellulose and water soluble salts of cellulose ethers (e.g.,        sodium carboxymethyl cellulose and sodium carboxymethyl        hydroxyethyl cellulose)    -   1.82 Any of the preceding compositions, wherein the compositions        comprises sodium carboxymethyl cellulose (e.g., from 0.5 wt.        %-1.5 wt. %).    -   1.83 Any of the preceding compositions comprising from 5%-40%,        e.g., 10%-35%, e.g., about 15%, 25%, 30%, and 35% water.    -   1.84 Any of the preceding compositions comprising an additional        antibacterial agent selected from halogenated diphenyl ether        (e.g. triclosan), herbal extracts and essential oils (e.g.,        rosemary extract, tea extract, magnolia extract, thymol,        menthol, eucalyptol, geraniol, carvacrol, citral, honokiol,        catechol, methyl salicylate, epigallocatechin gallate,        epigallocatechin, gallic acid, miswak extract, sea-buckthorn        extract), bisguanide antiseptics (e.g., chlorhexidine, alexidine        or octenidine), quaternary ammonium compounds (e.g.,        cetylpyridinium chloride (CPC), benzalkonium chloride,        tetradecylpyridinium chloride (TPC),        N-tetradecyl-4-ethylpyridinium chloride (TDEPC)), phenolic        antiseptics, hexetidine, octenidine, sanguinarine, povidone        iodine, delmopinol, salifluor, metal ions (e.g., zinc salts and        zinc compounds, for example, Zinc Chloride, Zinc Lactate, Zinc        Sulfate, Zinc Oxide, stannous salts, copper salts, iron salts),        sanguinarine, propolis and oxygenating agents (e.g., hydrogen        peroxide, buffered sodium peroxyborate or peroxycarbonate),        phthalic acid and its salts, monoperthalic acid and its salts        and esters, ascorbyl stearate, oleoyl sarcosine, alkyl sulfate,        dioctyl sulfosuccinate, salicylanilide, domiphen bromide,        delmopinol, octapinol and other piperidine derivatives, nicin        preparations, chlorite salts; and mixtures of any of the        foregoing.    -   1.85 Any of the preceding compositions comprising an        antioxidant, e.g., selected from the group consisting of        Co-enzyme Q10, PQQ, Vitamin C, Vitamin E, Vitamin A, BUT,        anethole-dithiothione, and mixtures thereof.    -   1.86 Any of the preceding compositions comprising a whitening        agent.    -   1.87 Any of the preceding compositions comprising a whitening        agent selected from a whitening active selected from the group        consisting of peroxides, metal chlorites, perborates,        percarbonates, peroxyacids, hypochlorites, and combinations        thereof.    -   1.88 Any of the preceding compositions further comprising        hydrogen peroxide or a hydrogen peroxide source, e.g., urea        peroxide or a peroxide salt or complex (e.g., such as        peroxyphosphate, peroxycarbonate, perborate, peroxysilicate, or        persulphate salts; for example calcium peroxyphosphate, sodium        perborate, sodium carbonate peroxide, sodium peroxyphosphate,        and potassium persulfate), or hydrogen peroxide polymer        complexes such as hydrogen peroxide-polyvinyl pyrrolidone        polymer complexes.    -   1.89 Any of the preceding compositions further comprising an        agent that interferes with or prevents bacterial attachment,        e.g., ethyl lauryl arginate (ELA) or chitosan.    -   1.90 Any of the preceding compositions comprising:        -   a. about 1.0% zinc oxide        -   b. about 0.5% zinc citrate        -   c. about 1.5% L-arginine        -   d. about 0.32% sodium fluoride;        -   e. about 3 wt. % to 15 wt. % silica abrasive which exhibits            an acid pH when measured as an aqueous slurry (e.g., prophy            silica) (e.g., Sylodent 783)    -   1.91 Any of the preceding compositions comprising:        -   a. about 1.0% zinc oxide        -   b. about 0.5% zinc citrate        -   c. about 5% L-arginine        -   d. about 0.32% sodium fluoride        -   e. about 10 wt. % to 15 wt. % silica abrasive which exhibits            an acid pH when measured as an aqueous slurry (e.g., prophy            silica) (e.g., Sylodent 783), and    -   1.92 Any of the preceding compositions comprising:        -   a. about 1.0% zinc oxide        -   b. about 0.5% zinc citrate        -   c. about 5% L-arginine        -   d. about 0.32% sodium fluoride;        -   e. about 3 wt. % to 15 wt. % silica abrasive which exhibits            an acid pH when measured as an aqueous slurry (e.g., prophy            silica) (e.g., Sylodent 783)    -   1.93 Any of the preceding compositions comprising a silica,        wherein the silica is Zeodent 114.    -   1.94 Any of the preceding compositions effective upon        application to the oral cavity, e.g., by rinsing, optionally in        conjunction with brushing, to (i) reduce or inhibit formation of        dental caries, (ii) reduce, repair or inhibit pre-carious        lesions of the enamel, e.g., as detected by quantitative        light-induced fluorescence (QLF) or electrical caries        measurement (ECM), (iii) reduce or inhibit demineralization and        promote remineralization of the teeth, (iv) reduce        hypersensitivity of the teeth, (v) reduce or inhibit        gingivitis, (vi) promote healing of sores or cuts in the        mouth, (vii) reduce levels of acid producing bacteria, (viii) to        increase relative levels of arginolytic bacteria, (ix) inhibit        microbial biofilm formation in the oral cavity, (x) raise and/or        maintain plaque pH at levels of at least pH 5.5 following sugar        challenge, (xi) reduce plaque accumulation, (xii) treat, relieve        or reduce dry mouth, (xiii) clean the teeth and oral        cavity (xiv) reduce erosion, (xv) prevents stains and/or whiten        teeth, (xvi) immunize the teeth against cariogenic bacteria;        and/or (xvii) promote systemic health, including cardiovascular        health, e.g., by reducing potential for systemic infection via        the oral tissues.    -   1.95 Any of the preceding oral compositions, wherein the oral        composition may be any of the following oral compositions        selected from the group consisting of: a toothpaste or a        dentifrice, a mouthwash or a mouth rinse, a topical oral gel,        and a denture cleanser.    -   1.96 A composition obtained or obtainable by combining the        ingredients as set forth in any of the preceding compositions.    -   1.97 A composition obtained or obtainable by combining the        ingredients as set forth in any of the preceding compositions.    -   1.98 A composition for use as set for in any of the preceding        compositions.

In another embodiment, the invention encompasses a method to improveoral health comprising applying an effective amount of the oralcomposition of any of the embodiments set forth above (e.g., any ofComposition 1.0 et seq) to the oral cavity of a subject in need thereof,e.g.,

-   -   i. a method to reduce or inhibit formation of dental caries,        reduce, repair or inhibit early enamel lesions, e.g., as        detected by quantitative light-induced fluorescence (QLF) or        electrical caries measurement (ECM),    -   ii. reduce or inhibit demineralization and promote        remineralization of the teeth,    -   iii. reduce hypersensitivity of the teeth,    -   iv. reduce or inhibit gingivitis,    -   v. promote healing of sores or cuts in the mouth,    -   vi. reduce levels of acid producing bacteria,    -   vii. to increase relative levels of arginolytic bacteria,    -   viii. inhibit microbial bio film formation in the oral cavity,    -   ix. raise and/or maintain plaque pH at levels of at least pH 5.5        following sugar challenge,    -   x. reduce plaque accumulation,    -   xi. treat dry mouth,    -   xii. enhance systemic health, including cardiovascular health,        e.g., by reducing potential for systemic infection via the oral        tissues,    -   xiii. Whiten teeth,    -   xiv. reduce erosion of the teeth,    -   xv. immunize (or protect) the teeth against cariogenic bacteria        and their effects, and/or    -   xvi. clean the teeth and oral cavity.

The invention further comprises the use of sodium bicarbonate, sodiummethyl cocoyl taurate (tauranol), methylisothiazolinone, and benzylalcohol and combinations thereof in the manufacture of a Composition ofthe Invention, e.g., for use in any of the indications set forth in theabove method of Composition 1.0, et seq.

DETAILED DESCRIPTION

As used herein, the term “oral composition” means the total compositionthat is delivered to the oral surfaces. The composition is furtherdefined as a product which, during the normal course of usage, is not,the purposes of systemic administration of particular therapeuticagents, intentionally swallowed but is rather retained in the oralcavity for a time sufficient to contact substantially all of the dentalsurfaces and/or oral tissues for the purposes of oral activity. Examplesof such compositions include, but are not limited to, toothpaste or adentifrice, a mouthwash or a mouth rinse, a topical oral gel, a denturecleanser, and the like.

As used herein, the term “dentifrice” means paste, gel, or liquidformulations unless otherwise specified. The dentifrice composition canbe in any desired form such as deep striped, surface striped,multi-layered, having the gel surrounding the paste, or any combinationthereof. Alternatively the oral composition is provided as a dual phasecomposition, wherein individual compositions are combined when dispensedfrom a separated compartment dispenser.

Basic Amino Acids

The basic amino acids which can be used in the compositions and methodsof the invention include not only naturally occurring basic amino acids,such as arginine, lysine, and histidine, but also any basic amino acidshaving a carboxyl group and an amino group in the molecule, which arewater-soluble and provide an aqueous solution with a pH of 7 or greater.

Accordingly, basic amino acids include, but are not limited to,arginine, lysine, serine, citrullene, ornithine, creatine, histidine,diaminobutanoic acid, diaminoproprionic acid, salts thereof orcombinations thereof. In a particular embodiment, the basic amino acidsare selected from arginine, citrullene, and ornithine.

In certain embodiments, the basic amino acid is arginine, for example,L-arginine, or a salt thereof.

The compositions of the invention are intended for topical use in themouth and so salts for use in the present invention should be safe forsuch use, in the amounts and concentrations provided. Suitable saltsinclude salts known in the art to be pharmaceutically acceptable saltswhich are generally considered to be physiologically acceptable in theamounts and concentrations provided. Physiologically acceptable saltsinclude those derived from pharmaceutically acceptable inorganic ororganic acids or bases, for example acid addition salts formed by acidswhich form a physiological acceptable anion, e.g., hydrochloride orbromide salt, and base addition salts formed by bases which form aphysiologically acceptable cation, for example those derived from alkalimetals such as potassium and sodium or alkaline earth metals such ascalcium and magnesium. Physiologically acceptable salts may be obtainedusing standard procedures known in the art, for example, by reacting asufficiently basic compound such as an amine with a suitable acidaffording a physiologically acceptable anion.

Fluoride Ion Source

The oral care compositions may further include one or more fluoride ionsources, e.g., soluble fluoride salts. A wide variety of fluorideion-yielding materials can be employed as sources of soluble fluoride inthe present compositions. Examples of suitable fluoride ion-yieldingmaterials are found in U.S. Pat. No. 3,535,421, to Briner et al.; U.S.Pat. No. 4,885,155, to Parran, Jr. et al. and U.S. Pat. No. 3,678,154,to Widder et al., each of which are incorporated herein by reference.Representative fluoride ion sources used with the present invention(e.g., Composition 1.0 et seq.) include, but are not limited to,stannous fluoride, sodium fluoride, potassium fluoride, sodiummonofluorophosphate, sodium fluorosilicate, ammonium fluorosilicate,amine fluoride, ammonium fluoride, and combinations thereof. In certainembodiments the fluoride ion source includes stannous fluoride, sodiumfluoride, sodium monofluorophosphate as well as mixtures thereof. Wherethe formulation comprises calcium salts, the fluoride salts arepreferably salts wherein the fluoride is covalently bound to anotheratom, as in sodium monofluorophosphate, rather than merely ionicallybound, e.g., as in sodium fluoride.

Surfactants

The invention may in some embodiments contain anionic surfactants, e.g.,the Compositions of Composition 1.0, et seq., for example, water-solublesalts of higher fatty acid monoglyceride monosulfates, such as thesodium salt of the monosulfated monoglyceride of hydrogenated coconutoil fatty acids such as sodium N-methyl N-cocoyl taurate, sodiumcoca-glyceride sulfate; higher alkyl sulfates, such as sodium laurylsulfate; higher alkyl-ether sulfates, e.g., of formulaCH₃(CH₂)_(m)CH₂(OCH₂CH₂)_(n)OS0₃X, wherein m is 6-16, e.g., 10, n is1-6, e.g., 2, 3 or 4, and X is Na or, for example sodium laureth-2sulfate (CH₃(CH2)₁₀CH₂(OCH₂CH₂)₂OS0₃Na); higher alkyl aryl sulfonatessuch as sodium dodecyl benzene sulfonate (sodium lauryl benzenesulfonate); higher alkyl sulfoacetates, such as sodium laurylsulfoacetate (dodecyl sodium sulfoacetate), higher fatty acid esters of1,2 dihydroxy propane sulfonate, sulfocolaurate (N-2-ethyl lauratepotassium sulfoacetamide) and sodium lauryl sarcosinate. By “higheralkyl” is meant, e.g., C₆-₃o alkyl. In particular embodiments, theanionic surfactant (where present) is selected from sodium laurylsulfate and sodium ether lauryl sulfate. When present, the anionicsurfactant is present in an amount which is effective, e.g., >0.001% byweight of the formulation, but not at a concentration which would beirritating to the oral tissue, e.g., 1%, and optimal concentrationsdepend on the particular formulation and the particular surfactant. Inone embodiment, the anionic surfactant is present at from 0.03% to 5% byweight, e.g., 1.5%.

Cationic surfactants useful in the present invention can be broadlydefined as derivatives of aliphatic quaternary ammonium compounds havingone long alkyl chain containing 8 to 18 carbon atoms such as lauryltrimethylammonium chloride, cetyl pyridinium chloride, cetyltrimethylammonium bromide, di-isobutylphenoxyethyldimethylbenzylammoniumchloride, coconut alkyltrimethylammonium nitrite, cetyl pyridiniumfluoride, and mixtures thereof. Illustrative cationic surfactants arethe quaternary ammonium fluorides described in U.S. Pat. No. 3,535,421,to Briner et al., herein incorporated by reference. Certain cationicsurfactants can also act as germicides in the compositions.

Illustrative nonionic surfactants of Composition 1.0, et seq., that canbe used in the compositions of the invention can be broadly defined ascompounds produced by the condensation of alkylene oxide groups(hydrophilic in nature) with an organic hydrophobic compound which maybe aliphatic or alkylaromatic in nature. Examples of suitable nonionicsurfactants include, but are not limited to, the Pluronics, polyethyleneoxide condensates of alkyl phenols, products derived from thecondensation of ethylene oxide with the reaction product of propyleneoxide and ethylene diamine, ethylene oxide condensates of aliphaticalcohols, long chain tertiary amine oxides, long chain tertiaryphosphine oxides, long chain dialkyl sulfoxides and mixtures of suchmaterials. In a particular embodiment, the composition of the inventioncomprises a nonionic surfactant selected from polaxamers (e.g.,polaxamer 407), polysorbates (e.g., polysorbate 20), polyoxylhydrogenated castor oils (e.g., polyoxyl 40 hydrogenated castor oil),and mixtures thereof.

Illustrative amphoteric surfactants of Composition 1.0, et seq., thatcan be used in the compositions of the invention include betaines (suchas cocamidopropylbetaine), derivatives of aliphatic secondary andtertiary amines in which the aliphatic radical can be a straight orbranched chain and wherein one of the aliphatic substituents containsabout 8-18 carbon atoms and one contains an anionic water-solubilizinggroup (such as carboxylate, sulfonate, sulfate, phosphate orphosphonate), and mixtures of such materials.

Illustrative zwitterionic surfactants of Composition 1.0, et seq., thatcan be used in the compositions of the invention include derivatives ofaliphatic quaternary ammonium, phosphonium and sulfonium compounds inwhich the aliphatic radical can be a straight or branched chain andwherein one of the aliphatic substituents contains about 8-18 carbonatoms and one contains an anionic water-solubilizing group (such ascarboxy, sulfonate, sulfate, phosphate or phosphonate). The surfactantor mixtures of compatible surfactants can be present in the compositionsof the present invention in 0.1% to 5%, in another embodiment 0.3% to 3%and in another embodiment 0.5% to 2% by weight of the total composition.

Flavoring Agents

The oral care compositions of the invention may also include a flavoringagent. Flavoring agents which are used in the practice of the presentinvention include, but are not limited to, essential oils and variousflavoring aldehydes, esters, alcohols, and similar materials, as well assweeteners such as sodium saccharin. Examples of the essential oilsinclude oils of spearmint, peppermint, wintergreen, sassafras, clove,sage, eucalyptus, marjoram, cinnamon, lemon, lime, grapefruit, andorange. Also useful are such chemicals as menthol, carvone, andanethole. Certain embodiments employ the oils of peppermint andspearmint.

The flavoring agent is incorporated in the oral composition at aconcentration of 0.01 to 1% by weight.

Chelating and Anti-Calculus Agents

The oral care compositions of the invention (e.g., Composition 1.0 etseq) also may include one or more chelating agents able to complexcalcium found in the cell walls of the bacteria. Binding of this calciumweakens the bacterial cell wall and augments bacterial lysis.

Another group of agents suitable for use as chelating or anti-calculusagents in the present invention are the soluble pyrophosphates. Thepyrophosphate salts used in the present compositions can be any of thealkali metal pyrophosphate salts. In certain embodiments, salts includetetra alkali metal pyrophosphate, dialkali metal diacid pyrophosphate,trialkali metal monoacid pyrophosphate and mixtures thereof, wherein thealkali metals are sodium or potassium. The salts are useful in boththeir hydrated and unhydrated forms. An effective amount ofpyrophosphate salt useful in the present composition is generally enoughto provide least 0.1 wt. % pyrophosphate ions, e.g., 0.1 to 3 wt 5,e.g., 0.1 to 2 wt %, e.g., 0.1 to 1 wt %, e.g., 0.2 to 0.5 wt %. Thepyrophosphates also contribute to preservation of the compositions bylowering the effect of water activity.

Polymers

The oral care compositions of the invention (e.g., Composition 1.0, etseq) also optionally include one or more polymers, such as polyethyleneglycols, polyvinyl methyl ether maleic acid copolymers, polysaccharides(e.g., cellulose derivatives, for example carboxymethyl cellulose, orpolysaccharide gums, for example xanthan gum or carrageenan gum). Acidicpolymers, for example polyacrylate gels, may be provided in the form oftheir free acids or partially or fully neutralized water soluble alkalimetal (e.g., potassium and sodium) or ammonium salts. Certainembodiments include 1:4 to 4:1 copolymers of maleic anhydride or acidwith another polymerizable ethylenically unsaturated monomer, forexample, methyl vinyl ether (methoxyethylene) having a molecular weight(M.W.) of about 30,000 to about 1,000,000. These copolymers areavailable for example as Gantrez AN 139 (M.W. 500,000), AN 1 19 (M.W.250,000) and S-97 Pharmaceutical Grade (M.W. 70,000), of GAF ChemicalsCorporation.

Other operative polymers include those such as the 1:1 copolymers ofmaleic anhydride with ethyl acrylate, hydroxyethyl methacrylate,N-vinyl-2-pyrollidone, or ethylene, the latter being available forexample as Monsanto EMA No. 1 103, M.W. 10,000 and EMA Grade 61, and 1:1copolymers of acrylic acid with methyl or hydroxyethyl methacrylate,methyl or ethyl acrylate, isobutyl vinyl ether or N-vinyl-2-pyrrolidone.

Suitable generally, are polymerized olefinically or ethylenicallyunsaturated carboxylic acids containing an activated carbon-to-carbonolefinic double bond and at least one carboxyl group, that is, an acidcontaining an olefinic double bond which readily functions inpolymerization because of its presence in the monomer molecule either inthe alpha-beta position with respect to a carboxyl group or as part of aterminal methylene grouping. Illustrative of such acids are acrylic,methacrylic, ethacrylic, alpha-chloroacrylic, crotonic, beta-acryloxypropionic, sorbic, alpha-chlorosorbic, cinnamic, beta-styrylacrylic,muconic, itaconic, citraconic, mesaconic, glutaconic, aconitic,alpha-phenylacrylic, 2-benzyl acrylic, 2-cyclohexylacrylic, angelic,umbellic, fumaric, maleic acids and anhydrides. Other different olefinicmonomers copolymerizable with such carboxylic monomers includevinylacetate, vinyl chloride, dimethyl maleate and the like. Copolymerscontain sufficient carboxylic salt groups for water-solubility.

A further class of polymeric agents includes a composition containinghomopolymers of substituted acrylamides and/or homopolymers ofunsaturated sulfonic acids and salts thereof, in particular wherepolymers are based on unsaturated sulfonic acids selected fromacrylamidoalykane sulfonic acids such as 2-acrylamide 2 methylpropanesulfonic acid having a molecular weight of about 1,000 to about2,000,000, described in U.S. Pat. No. 4,842,847, Jun. 27, 1989 to Zahid,incorporated herein by reference.

Another useful class of polymeric agents includes polyamine acids,particularly those containing proportions of anionic surface-activeamino acids such as aspartic acid, glutamic acid and phosphoserine, asdisclosed in U.S. Pat. No. 4,866,161 Sikes et al., incorporated hereinby reference.

In preparing oral care compositions, it is sometimes necessary to addsome thickening material to provide a desirable consistency or tostabilize or enhance the performance of the formulation. In certainembodiments, the thickening agents are carboxyvinyl polymers,carrageenan, xanthan gum, hydroxyethyl cellulose and water soluble saltsof cellulose ethers such as sodium carboxymethyl cellulose and sodiumcarboxymethyl hydroxyethyl cellulose. Natural gums such as karaya, gumarabic, and gum tragacanth can also be incorporated. Colloidal magnesiumaluminum silicate or finely divided silica can be used as component ofthe thickening composition to further improve the composition's texture.In certain embodiments, thickening agents in an amount of about 0.5% toabout 5.0% by weight of the total composition are used,

Abrasives

Generally, the inclusion of abrasives in dentifrice formulations isnecessary for effective cleaning of teeth by brushing. It has beendetermined that by including an abrasive silica having an acid pH in thecomposition, compositions of enhanced viscosity stability are obtained.Prophy silica available from Grace, offered as Sylodent™, can be usedwith various embodiments of the present invention (e.g., Composition 1.0et seq).

The acidic silica abrasive is included in the dentifrice components at aconcentration of about 2 to about 35% by weight; about 3 to about 20% byweight, about 3 to about 15% by weight, about 10 to about 15% by weight.For example, the acidic silica abrasive may be present in an amountselected from 2 wt. %, 3 wt. %, 4% wt. %, 5 wt. %, 6 wt. %, 7 wt. %, 8wt. %, 9 wt. %, 10 wt. %, 11 wt. %, 12 wt. %, 13 wt. %, 14 wt. %, 15 wt.%, 16 wt. %, 17 wt. %, 18 wt. %, 19 wt %, 20 wt. %.

A commercially available acidic silica abrasive is Sylodent 783available from W. R. Grace & Company, Baltimore, Md. Sylodent 783 has apH of 3.4-4.2 when measured as a 5% by weight slurry in water. For usein the present invention, the silica material has an average particlesize of less than 10 microns, e.g., 3-7 microns, e.g. about 5.5 microns.For example a small particle silica may have an average particle size(D50) of 2.5-4.5 microns.

The composition may also include any silica suitable for oral carecompositions, such as precipitated silicas or silica gels. For examplesynthetic amorphous silica. Silica may also be available as a thickeningagent, e.g., particle silica. For example, the silica can also be smallparticle silica (e.g., Sorbosil AC43 from PQ Corporation, Warrington,United Kingdom). However the additional abrasives are preferably notpresent in a type or amount so as to increase the RDA of the dentifriceto levels which could damage sensitive teeth, e.g., greater than 130.

The invention may also comprise a commercially available cleaning silicain certain embodiments of the invention (e.g., any of Composition 1.0,et seq). Zeodent 114 offered by J. M. Huber Finland Cay Telakkatie 5FIN-49460 Hamina, is one such commercially available silica.

Water

Water is present in the oral compositions of the invention. Water,employed in the preparation of commercial oral compositions should bedeionized and free of organic impurities. Water commonly makes up thebalance of the compositions and includes 5% to 45%, e.g., 10% to 20%,e.g., 25%-35%, by weight of the oral compositions. This amount of waterincludes the free water which is added plus that amount which isintroduced with other materials such as with sorbitol or silica or anycomponents of the invention. The Karl Fischer method is a one measure ofcalculating free water.

Humectants

Within certain embodiments of the oral compositions (e.g., Composition1.0 et seq), it is also desirable to incorporate a humectant to reduceevaporation and also contribute towards preservation by lowering wateractivity. Certain humectants can also impart desirable sweetness orflavor to the compositions. The humectant, on a pure humectant basis,generally includes 15% to 70% in one embodiment or 30% to 65% in anotherembodiment by weight of the composition.

Suitable humectants include edible polyhydric alcohols such asglycerine, sorbitol, xylitol, propylene glycol as well as other polyolsand mixtures of these humectants. Mixtures of glycerine and sorbitol maybe used in certain embodiments as the humectant component of thecompositions herein.

The present invention in its method aspect involves applying to the oralcavity a safe and effective amount of the compositions described herein.

The compositions and methods according to the invention (e.g.,Composition 1.0 et seq) can be incorporated into oral compositions forthe care of the mouth and teeth such as toothpastes, transparent pastes,gels, mouth rinses, sprays and chewing gum.

As used throughout, ranges are used as shorthand for describing each andevery value that is within the range. Any value within the range can beselected as the terminus of the range. In addition, all references citedherein are hereby incorporated by reference in their entireties. In theevent of a conflict in a definition in the present disclosure and thatof a cited reference, the present disclosure controls. It is understoodthat when formulations are described, they may be described in terms oftheir ingredients, as is common in the art, notwithstanding that theseingredients may react with one another in the actual formulation as itis made, stored and used, and such products are intended to be coveredby the formulations described.

The following examples further describe and demonstrate illustrativeembodiments within the scope of the present invention. The examples aregiven solely for illustration and are not to be construed as limitationsof this invention as many variations are possible without departing fromthe spirit and scope thereof. Various modifications of the invention inaddition to those shown and described herein should be apparent to thoseskilled in the art and are intended to fall within the appended claims.

EXAMPLES Example 1

The examples herein detail how the viscosity over time for a compositionwhich exhibits a problem of rapid reduction in viscosity (Run A), iscompared to five compositions which show the stabilized viscosityprovided by the invention (Compositions 1-5 in Table 1).

Viscosity is measured on a Brookfield HADV2 viscometer using a V74 vanespindle. This viscometer applies a user-controlled angular velocity tothe spindle, typically measured in rotations per second (RPM), andreports torque on the shaft of the spindle. Viscosity is then calculatedfrom RPM and torque as explained in the Brookfield Manual (OperatingInstructions) using too conversion parameters SRC (shear rate constant)and SMC (spindle multiplier constant). The conversion parameters aredefined as follows: SMC=290, SRC=0.2723. The test is performed at roomtemperature, and varies between 22 and 25 deg. C. During the test, RPMof the spindle is swept from 200 to 0.5 in 12 steps, 10 seconds perstep. The viscosity reading reported is taken at RPM=1.

Compositions containing zinc oxide, zinc citrate, arginine and afluoride source are prepared as described in Table 1, below. Allcompositions are formulated to provide a 10% pH of 8-8.5 using 0-0.35%phosphoric acid. The composition identified as Run A does not contain asilica abrasive which exhibits an acid pH when measured as an aqueousslurry. The compositions identified as Compositions 1-5 in Table 1contain a silica abrasive which exhibits an acid pH (Prophy SilicaSylodent 783) when measured as an aqueous slurry in varying amounts, asdetailed below.

TABLE 1 Dentifrice Formulations Experiment ID INGREDIENTS Run AComposition 1 Composition 2 Composition 3 Composition 4 Composition 599.0%-101.0% 35 35 35 35 35 35 GLYCERIN - USP, EP VEG DEMINERALIZED Q.S.Q.S. Q.S. Q.S. Q.S. Q.S. WATER PROPHY 0 15 10 5 5 3 SILICA (SYLODENT783) ABRASIVES (e.g., 20 5 10 15 15 17 includes Abrasive silcas, HighCleaning Silicas) SILICA- 6.5 7 7 7 7 7 THICKENER ANIONIC 2 2 2 2 2 2SURFACTANT L-ARGININE 1.5 1.5 1.5 1.5 1.5 1.5 AMPHOTERIC 1.25 1.25 1.251.25 1.25 1.25 SURFACTANT NON-IONIC 0.75 0.75 0.75 0.75 0.75 0.75SURFACTANT ZINC OXIDE 1 1 1 1 1 1 POLYMER 1 1.3 1.3 3.3 1.3 1.3 COLORANT0.75 0.75 0.75 0.75 0.75 0.75 ALKALI 0.5 0.5 0.5 0.5 0.5 0.5 PHOSPHATESALT ZINC 0.5 0.5 0.5 0.5 0.5 0.5 CITRATE TRIHYDRATE PRESERVATIVE 0.40.4 0.4 0.4 0.4 0.4 SODIUM 0.32 0.32 0.32 0.32 0.32 0.32 FLUORIDE - USP,EP 85% SYRUPY 0.35 0 0 0 0 0 PHOSPHORIC ACID - FOOD GRADE FLAVORING 2 22 2 1.82 1.52 AGENT TOTAL 100 100 100 100 100 100 COMPONENTS

The composition identified as Run A displays an initial viscosity whichis initially 500,000 cps to 600,000 cps high, but decreases to under400,000 cps in 2 weeks, and under 200,000 cps at 6 weeks. Surprisingly,the compositions containing a silica abrasive which exhibits an acid pH(Prophy Silica—Sylodent 783) when measured as an aqueous slurry,Compositions 1 to 5 in Table 1, eliminate this undesirablecharacteristic and instead produce viscosities that are stable orincrease over time (See, Table 2).

TABLE 2 Viscosity data. Experiment ID Run A Composition 1 Composition 2Composition 3 Composition 4 Composition 5 Time Viscosity (cps) 0 491040363489 1 d  539119 211912 300155 272475 5 d  601597 309816 1 wk 627362288561 383245 371651 2 wk 433485 340733 328495 403212 364565 3 wk 343310314325 334292 4 wk 224794 395483 304019 430909 423823 5 wk 375515 338801322698 6 wk 193233 376804 344598 334292 406432 442503 7 wk 334292 9 wk387753 10 wk  351039 364565 11 wk  158451 373583 381956 12 wk  405788357480 13 wk  405788 398059 393550

Upon further investigation, it was found that the silica abrasive whichexhibits an acid pH when measured as an aqueous slurry silica is acidic(pH 3.4-4.2) does not require phosphoric acid to adjust the product pH.Other abrasive silicas and high cleaning silicas are about neutral in pH(pH 7-8) and thus, require phosphoric acid for pH adjustment.

TABLE 3 Viscosity Data Composition 6 Composition 7 Composition 8Demineralized Water Q.S. Q.S. Q.S. Glycerin - 99.5% 35 35 35 Polymer 1.21.2 1.2 Zinc Oxide 1 1 1 Zinc Citrate 0.5 0.5 0.5 Alkali Phosphate Salt0.5 0.5 0.5 Flavoring agent 1.82 1.82 1.82 Sodium Fluoride 0.32 0.320.32 Colorant 0.75 0.75 0.75 L-Arginine 1.5 1.5 1.5 Non-Ionic Surfactant0.5 0.5 0.5 Abrasives (e.g., 8 10 12 includes Abrasive Silcas, HighCleaning Silicas) Prophy silica 7 5 3 (Sylodent 783) Silica - thickener7 7 8.5 Preservative 0.4 0.4 0.4 Anionic Surfactant 5.7 5.7 5.7Amphoteric Surfactant 1.25 1.25 1.25 Total Components 100 100 100

Upon further investigation, when phosphoric acid is removed from furtherformulations (Compositions 6-8 in Table 3), they demonstrate improvementin viscosity stability, and this viscosity trend remained relativelystable from day 1 to 4 weeks when tested at: room temperature, 40° C.,and 49° C. The data is further detailed in Table 4 below.

TABLE 4 Composition 6 Composition 7 Composion 8 Viscosity, 10³ cpsViscosity, 10³ cps Viscosity, 10³ cps RT 40 C. 49 C. RT 40 C. 49 C. RT40 C. 49 C. 0 471 324 336 0.14 370 197 268 1 363 418 390 200 227 258 230256 263 2 360 430 440 201 243 269 220 250 258 3 325 205 246 245 228 277274 4 314 412 385 224 253 253 227 268 979 6 327 218 233

As used throughout, ranges are used as shorthand for describing each andevery value that is within the range. Any value within the range can beselected as the terminus of the range. In addition, all references citedherein are hereby incorporated by referenced in their entireties. In theevent of a conflict in a definition in the present disclosure and thatof a cited reference, the present disclosure controls.

Unless otherwise specified, all percentages and amounts expressed hereinand elsewhere in the specification should be understood to refer topercentages by weight. The amounts given are based on the active weightof the material.

While the present invention has been described with reference toembodiments, it will be understood by those skilled in the art thatvarious modifications and variations may be made therein withoutdeparting from the scope of the present invention as defined by theappended claims.

What is claimed is:
 1. An oral care composition comprising: a. a basicamino acid in free or salt form wherein the amino acid is arginine; b.zinc oxide and zinc citrate; c. a fluoride source; and d. a silicaabrasive which exhibits a pH of 3.4-4.2 when measured as an aqueousslurry, wherein said silica abrasive is present in an amount of about 3wt. % to about 15 wt. % based on the total weight of the composition;and wherein the oral care composition increases viscosity over 2-13weeks after aging, or does not drop more than 18% in viscosity over 2-13weeks of ageing, wherein the aging is measured from day
 1. 2. The oralcare composition of claim 1, wherein the arginine has anL-configuration; and wherein the arginine is present in an amountcorresponding to 1 wt. % to 15 wt. %, based on the total weight of thecomposition, the weight of the arginine being calculated as free form.3. The oral care composition of claim 1 wherein the arginine is presentin the amount of about 1.5 wt. %, 5.0 wt. % or 8.0 wt. %, based on thetotal weight of the composition.
 4. The oral care composition of claim1, wherein the arginine is in free form.
 5. The oral care composition ofclaim 1, wherein the ratio of the amount of zinc oxide to zinc citrateis 2:1, 2.5:1, 3:1, 3.5:1 or 4:1, wherein the ratio is by wt. of theoverall composition.
 6. The oral care composition of claim 1, whereinthe zinc citrate is in an amount of from 0.25 to 1.0 wt % and the zincoxide is in an amount of from 0.75 to 1.25 wt % based on the totalweight of the oral care composition.
 7. The oral care composition ofclaim 1, wherein the zinc citrate is in an amount of about 0.5 wt % andthe zinc oxide is in an amount of about 1.0% based on the total weightof the oral care composition.
 8. The oral care composition of claim 1,wherein the fluoride source is sodium fluoride or sodiummonofluorophosphate.
 9. The oral care composition of claim 8, whereinthe sodium fluoride or sodium monofluorophosphate is from 0.1 wt. %-2wt. % of the total composition weight.
 10. The composition of claim 1,wherein the fluoride source is stannous fluoride.
 11. The oral carecomposition of claim 1, further comprising an additional ingredientselected from: benzyl alcohol, methylisothiazolinone (MIT), sodiumbicarbonate, sodium methyl cocoyl taurate, lauryl alcohol, andpolyphosphate.
 12. The oral care composition of claim 11 wherein benzylalcohol is present from 0.1-0.6% wt, based on the total weight of thecomposition.
 13. The oral care composition of claim 1 comprising: a.about 1.0% zinc oxide b. about 0.5% zinc citrate c. about 1.5%L-arginine d. about 0.32% sodium fluoride; e. about 3 wt. % to 15 wt. %silica abrasive which exhibits a pH of 3.4-4.2 when measured as anaqueous slurry; wherein the amounts are based on the total weight of thecomposition.
 14. The oral care composition of claim 1 comprising: a.about 1.0% zinc oxide b. about 0.5% zinc citrate c. about 5% L-arginined. about 0.32% sodium fluoride; e. about 10 wt. % to 15 wt. % silicaabrasive which exhibits a pH of 3.4-4.2 when measured as an aqueousslurry; wherein the amounts are based on the total weight of thecomposition.
 15. The oral care composition of claim 1, wherein the oralcomposition may be any of the following oral compositions selected fromthe group consisting of: a toothpaste or a dentifrice, a mouthwash or amouth rinse, a topical oral gel, and a denture cleanser.
 16. A method toimprove oral health comprising applying an effective amount of the oralcomposition of claim 1, to the oral cavity of a subject in need thereof,wherein the method is effective to: i. reduce or inhibit formation ofdental caries, ii. reduce, repair or inhibit early enamel lesions, iii.reduce or inhibit demineralization and promote remineralization of theteeth, iv. reduce hypersensitivity of the teeth, v. reduce or inhibitgingivitis, vi. promote healing of sores or cuts in the mouth, vii.reduce levels of acid producing bacteria, viii. increase relative levelsof arginolytic bacteria, ix. inhibit microbial bio film formation in theoral cavity, x. raise and/or maintain plaque pH at levels of at least pH5.5 following sugar challenge, xi. reduce plaque accumulation, xii.treat dry mouth, xiii. enhance systemic health, xiv. whiten teeth, xv.reduce erosion of the teeth, xvi. immunize or protect the teeth againstcariogenic bacteria and their effects, and/or xvii. clean the teeth andoral cavity.